Sitagliptin SUN

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
27-10-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
27-10-2022
Public Assessment Report Public Assessment Report (PAR)
17-01-2022

Active ingredient:

sitagliptin fumarate

Available from:

Sun Pharmaceutical Industries Europe B.V.

ATC code:

A10BH01

INN (International Name):

sitagliptin fumarate

Therapeutic group:

Zdravila, ki se uporabljajo pri diabetesu

Therapeutic area:

Diabetes Mellitus, tip 2

Therapeutic indications:

For adult patients with type 2 diabetes mellitus, Sitagliptin SUN is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin SUN is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Product summary:

Revision: 1

Authorization status:

Pooblaščeni

Authorization date:

2021-12-09

Patient Information leaflet

                                24
EXP
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Nizozemska
EU/1/21/1598/001
28 filmsko obloženih tablet
EU/1/21/1598/002
56 filmsko obloženih tablet
EU/1/21/1598/003
98 filmsko obloženih tablet
EU/1/21/1598/004
90 filmsko obloženih tablet
Lot
sitagliptin sun 25 mg
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
PC
SN
NN
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
13.
ŠTEVILKA SERIJE
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
25
26
Sitagliptin SUN 25 mg filmsko obložene tablete
sitagliptin
Logotip Sun Pharma
EXP
Lot
1.
IME ZDRAVILA
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
4.
ŠTEVILKA SERIJE
5.
DRUGI PODATKI
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PRETISNI OMOTI
27
Sitagliptin SUN 25 mg filmsko obložene tablete
sitagliptin
Ena filmsko obložena tableta vsebuje 25 mg sitagliptina v obliki
sitagliptinijevega fumarata.
Vsebuje tudi hidrogenirano ricinusovo olje. Za dodatne informacije
glejte letak.
filmsko obložena tableta
90 filmsko obloženih tablet
Pred uporabo preberite priloženo navodilo!
peroralna uporaba
Zdravilo shranjujte nedosegljivo otrokom!
EXP
1.
IME ZDRAVILA
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
3.
SEZNAM POMOŽNIH SNOVI
4.
FARMACEVTSKA OBLIKA IN VSEBINA
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
PODATKI NA PRIMARNI OVOJNINI
NALEPKA NA PLASTENKI
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
28
Logotip Sun Pharma
Lot
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJ
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Sitagliptin SUN 25 mg filmsko obložene tablete
Sitagliptin SUN 50 mg filmsko obložene tablete
Sitagliptin SUN 100 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Sitagliptin SUN 25 mg filmsko obložene tablete
Ena filmsko obložena tableta vsebuje 25 mg sitagliptina v obliki
sitagliptinijevega fumarata.
Pomožna(e) snov(i) z znanim učinkom:
Ena filmsko obložena tableta vsebuje 4 mg hidrogenirano ricinusovo
olje.
Sitagliptin SUN 50 mg filmsko obložene tablete
Ena filmsko obložena tableta vsebuje 50 mg sitagliptina v obliki
sitagliptinijevega fumarata.
Pomožna(e) snov(i) z znanim učinkom:
Ena filmsko obložena tableta vsebuje 8 mg hidrogenirano ricinusovo
olje.
Sitagliptin SUN 100 mg filmsko obložene tablete
Ena filmsko obložena tableta vsebuje 100 mg sitagliptina v obliki
sitagliptinijevega fumarata.
Pomožna(e) snov(i) z znanim učinkom:
Ena filmsko obložena tableta vsebuje 16 mg hidrogenirano ricinusovo
olje.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
filmsko obložena tableta.
Sitagliptin SUN 25 mg filmsko obložene tablete
Svetlo rožnate, okrogle filmsko obložene tablete, dimenzij
približno 6 mm x 3 mm, z vtisnjeno oznako
F1 na eni strani in brez oznake na drugi strani.
Sitagliptin SUN 50 mg filmsko obložene tablete
Svetlo bež barve, okrogle filmsko obložene tablete, dimenzij
približno 8 mm x 4 mm, z vtisnjeno
oznako F2 na eni strani in brez oznake na drugi strani.
Sitagliptin SUN 100 mg filmsko obložene tablete
Bež, okrogle filmsko obložene tablete, dimenzij približno 10 mm x
4,5 mm, z vtisnjeno oznako F3 na
eni strani in brez oznake na drugi strani.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
3
Pri odraslih bolnikih s sladkorno boleznijo tipa 2 je zdravilo
Sitagliptin SUN indicirano za izboljšanje
urejenosti glikemije:
kot samostojno zdravljenje:
•
pri bolnikih, pri katerih urejenost glikemije samo z dieto in s
telesno aktivnostjo ni zadostna,
zdravljenje z me
                                
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Similar products

Active ingredient sitagliptin fumarate

sitagliptin fumarate

ATC code A10BH01

A10BH01

Marketed by Sun Pharmaceutical Industries Europe B.V.

Sun Pharmaceutical Industries Europe B.V.

INN (International Name) sitagliptin fumarate

sitagliptin fumarate

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 27-10-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 27-10-2022
Public Assessment Report Public Assessment Report Bulgarian 17-01-2022
Patient Information leaflet Patient Information leaflet Spanish 27-10-2022
Summary of Product characteristics Summary of Product characteristics Spanish 27-10-2022
Public Assessment Report Public Assessment Report Spanish 17-01-2022
Patient Information leaflet Patient Information leaflet Czech 27-10-2022
Summary of Product characteristics Summary of Product characteristics Czech 27-10-2022
Public Assessment Report Public Assessment Report Czech 17-01-2022
Patient Information leaflet Patient Information leaflet Danish 27-10-2022
Summary of Product characteristics Summary of Product characteristics Danish 27-10-2022
Public Assessment Report Public Assessment Report Danish 17-01-2022
Patient Information leaflet Patient Information leaflet German 27-10-2022
Summary of Product characteristics Summary of Product characteristics German 27-10-2022
Public Assessment Report Public Assessment Report German 17-01-2022
Patient Information leaflet Patient Information leaflet Estonian 27-10-2022
Summary of Product characteristics Summary of Product characteristics Estonian 27-10-2022
Public Assessment Report Public Assessment Report Estonian 17-01-2022
Patient Information leaflet Patient Information leaflet Greek 27-10-2022
Summary of Product characteristics Summary of Product characteristics Greek 27-10-2022
Public Assessment Report Public Assessment Report Greek 17-01-2022
Patient Information leaflet Patient Information leaflet English 27-10-2022
Summary of Product characteristics Summary of Product characteristics English 27-10-2022
Public Assessment Report Public Assessment Report English 17-01-2022
Patient Information leaflet Patient Information leaflet French 27-10-2022
Summary of Product characteristics Summary of Product characteristics French 27-10-2022
Public Assessment Report Public Assessment Report French 17-01-2022
Patient Information leaflet Patient Information leaflet Italian 27-10-2022
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Public Assessment Report Public Assessment Report Italian 17-01-2022
Patient Information leaflet Patient Information leaflet Latvian 27-10-2022
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Public Assessment Report Public Assessment Report Latvian 17-01-2022
Patient Information leaflet Patient Information leaflet Lithuanian 27-10-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 27-10-2022
Public Assessment Report Public Assessment Report Lithuanian 17-01-2022
Patient Information leaflet Patient Information leaflet Hungarian 27-10-2022
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Public Assessment Report Public Assessment Report Hungarian 17-01-2022
Patient Information leaflet Patient Information leaflet Maltese 27-10-2022
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Public Assessment Report Public Assessment Report Maltese 17-01-2022
Patient Information leaflet Patient Information leaflet Dutch 27-10-2022
Summary of Product characteristics Summary of Product characteristics Dutch 27-10-2022
Public Assessment Report Public Assessment Report Dutch 17-01-2022
Patient Information leaflet Patient Information leaflet Polish 27-10-2022
Summary of Product characteristics Summary of Product characteristics Polish 27-10-2022
Public Assessment Report Public Assessment Report Polish 17-01-2022
Patient Information leaflet Patient Information leaflet Portuguese 27-10-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 27-10-2022
Public Assessment Report Public Assessment Report Portuguese 17-01-2022
Patient Information leaflet Patient Information leaflet Romanian 27-10-2022
Summary of Product characteristics Summary of Product characteristics Romanian 27-10-2022
Public Assessment Report Public Assessment Report Romanian 17-01-2022
Patient Information leaflet Patient Information leaflet Slovak 27-10-2022
Summary of Product characteristics Summary of Product characteristics Slovak 27-10-2022
Public Assessment Report Public Assessment Report Slovak 17-01-2022
Patient Information leaflet Patient Information leaflet Finnish 27-10-2022
Summary of Product characteristics Summary of Product characteristics Finnish 27-10-2022
Public Assessment Report Public Assessment Report Finnish 17-01-2022
Patient Information leaflet Patient Information leaflet Swedish 27-10-2022
Summary of Product characteristics Summary of Product characteristics Swedish 27-10-2022
Public Assessment Report Public Assessment Report Swedish 17-01-2022
Patient Information leaflet Patient Information leaflet Norwegian 27-10-2022
Summary of Product characteristics Summary of Product characteristics Norwegian 27-10-2022
Patient Information leaflet Patient Information leaflet Icelandic 27-10-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 27-10-2022
Patient Information leaflet Patient Information leaflet Croatian 27-10-2022
Summary of Product characteristics Summary of Product characteristics Croatian 27-10-2022
Public Assessment Report Public Assessment Report Croatian 17-01-2022

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